An interventional study of Randomizing for EPGB procedure and Randomizing for OAGB procedure in Bariatric Surgery Candidate, sponsored by L. van Hogezand. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-12.
Sponsored by L. van Hogezand · Not applicable, Interventional, and Treatment
The classic RYGB is in most patients with a BMI ≥45 technically not feasible. Two alternatives are the Extended Pouch Gastric Bypass and the One Anastomosis gastric bypass. In this single blinded randomized controlled trial the investigators aim to establish which technique leads to more weightloss in bariatric patients with a BMI ≥45.
Obesity is of increasing incidence worldwide. With it come major social-economical, medical and psychological problems which lead to high healthcare costs. Bariatric surgery is the most efficient treatment for morbid obesity, with the Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (GS) being the most performed.
The RYGB is preferable since this technique seems to lead to more reduction of obesity related comorbidities (DM2) and more weightloss in the long term. However, the RYGB is technically less feasible in patients with a BMI ≥45, due to less intra-abdominal space (excess fat in mesenterium) to connect the anastomosis tension-free.
An alternative for the RYGB are the Extended Pouch gastric bypass (EPGB) and the One-Anastomosis gastric bypass (OAGB). These techniques both involve an extended pouch which makes it easier to connect the anastomosis tension-free.
Furthermore, the extended pouch in the EPGB and OAGB could provide slower passage of food and stretches less on the longer term than the 'normal size'pouch in the RYGB, possibly leading to more weightloss (1,2).
Previous studies comparing the EPGB and RYGB showed more weightloss in patient undergoing EPGB and less weight gain in the long term (3). Other studies comparing the OAGB, RYGB and GS showed non-inferiority or even superiority of the OAGB for weightloss and remission of obesity related comorbidities as diabetes mellitus type 2 (DM2) and obstructive sleep apnea syndrome (OSAS) (4,5,6,7).
Theoretically the OAGB is a simpler procedure which reduces the risk of internal herniation and anastomotic leakage, since only one anastomosis is made (6,8) Only performing one anastomosis leads to less operating time, shorter time of anesthesia, and less usage of staple material. Which possibly makes this a safer and cheaper procedure.
Both techniques, EPGB and OAGB, seem to be adequate alternatives for the RYGB in patients with a BMI of 45 or higher. As of yet, the two techniques haven't been compared one to one. In this single blinded randomized controlled trial the investigators aim to establish which technique leads to more weightloss in bariatric patients with a BMI ≥45.
This is the only study on the registry with L. van Hogezand as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Classic gastric bypass with 2 anastomoses but with an extended pouch of 12-15cm and a biliary limb of 150cm.
Procedure: Randomizing for EPGB procedure
Gastric bypass with 1 anastomosis and an extended pouch of 12-15cm and a biliary limb of 150cm.
Procedure: Randomizing for OAGB procedure
Classic gastric bypass with 2 anastomoses but with an extended pouch of 12-15cm and a biliary limb of 150cm. Patients will be single blinded randomized for one of the two procedures. 125 patients will undergo EPGB and 125 patients will undergo OAGB. Pre-operatively, 6 months post-op and yearly post-op we will collect: weight, complications, revisions, comorbidities, blood samples and questionnaires.
Gastric bypass with 1 anastomosis and an extended pouch of 12-15cm and a biliary limb of 150cm. Patients will be single blinded randomized for one of the two procedures. 125 patients will undergo EPGB and 125 patients will undergo OAGB. Pre-operatively, 6 months post-op and yearly post-op we will collect: weight, complications, revisions, comorbidities, blood samples and questionnaires.
Weightloss short term
percentage excess weight loss
Time frame: 1, 3 and 5 years postoperatively
Weightloss long term
percentage excess weight loss
Time frame: 5-10 years postoperatively
Complications short term
bleeding, leakage, infections, intra-abdominal abcess, readmission, mortality
Time frame: up to 30 days postoperatively
Complications long term
vitamin/electrolyte deficiencies, internal herniation, marginal ulceration
Time frame: from 30 days until 10 years postoperatively
Revision of the bypass
Surgical revision of bypass
Time frame: until 10 years postoperatively
Comorbidities
Reduction of obesity-related comorbidites: diabetes mellitus type 2, hypertension, hypercholesterolemia, joint aches en obstructive sleep apnea syndrome
Time frame: until 10 years postoperatively
Deficiencies in blood - red blood count
Blood samples: red blood count
Time frame: until 10 years postoperatively
Deficiencies in blood - vitamins
Blood samples vitamins
Time frame: until 10 years postoperatively
Deficiencies in blood - electrolytes
Blood samples: electrolytes
Time frame: until 10 years postoperatively
Reflux/dumping questionnaire
Questionnaires for reflux and dumping complaints. scales 0-10, higher is worse outcome
Time frame: until 10 years postoperatively
Health related quality of life questionnaire
Questionnaires on HrQoL and patient satisfaction of procedure, scales 0-5 and 0-10, higher is worse outcome
Time frame: until 10 years postoperatively
Peroperative complications
Peroperative complications: bleeding, iatrogenic complications
Time frame: until 10 years postoperatively
Number of patients with peroperative conversion to sleeve
Conversion to sleeve when bypass not feasible
Time frame: until 10 years postoperatively
No study locations are listed for this record.
Plan to share: No — No sharing.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.